The Recall Desk
HighFDA (Devices)·Z-0023-2023·Announced 2022-10-19

Hobbs Posi-Stop Injection Needle recalled for incorrect expiration date on label

Hobbs Medical is recalling Posi-Stop Injection Needles (lot numbers ending in R) due to incorrect expiration dates on labels that extend shelf life. Affected devices were distributed in the US from March 2018 to September 2020.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving labeling errors on a sterile medical device where no illnesses or injuries have been reported. The hazard is theoretical—incorrect expiration dating on sterile devices could compromise sterility and performance if used beyond actual shelf life, meeting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles (Catalog Number 4718) because the device labels display an incorrect expiration date. The incorrect date extends the shelf life of the product.

Affected devices have lot numbers ending in R or are kits containing at least one device with a lot number ending in R. These devices were distributed worldwide, including in the United States, Canada, Austria, Belgium, Finland, and Norway. In the United States, distribution occurred from March 25, 2018 through September 28, 2020, and the labels on affected devices show expiration dates between November 1, 2022 and September 1, 2025.

Because the expiration date on the label is incorrect and extends beyond the actual shelf life, users may employ these devices beyond their intended safe period. Anyone with these devices should verify their product lot numbers to confirm whether they are affected.

The recalled product

Product
Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Injection Needle
Hazard
  • mislabeling
  • incorrect-expiration

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: M84947180 Lot Numbers: H11-17-176R

Distribution

Distributed nationwide across the United States.

Related recalls

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